FDA’s Lethal Regulations

FDA's Lethal Regulations
FDA’s Lethal Regulations

As with all regulatory agencies when left unchecked, the FDA causes great harm through its hyper-authoritarian stances and rules as well as preventing harm through other rules. It’s why such agencies, operating outside of legislation but having the force of law, need to be regularly checked and forced to defend their actions by properly elected officials.

A perfect case in point is the FDA’s lethal regulations that categorically and absolutely forbid drug manufacturers engaging in any form of speech which can be construed as describing or promoting a use of their drug(s) for any use other than an the FDA approved on-label use, even if the information about this other use is entirely truthful, totally non-misleading, and could help physicians better treat their patients.

As a result of the FDA’s interpretation of the Federal Food, Drug and Cosmetic Act (FDCA), manufacturers of pharmaceuticals may face severe penalties for disseminating truthful and non-misleading information about off-label uses before those uses are approved by the FDA. Indeed, some companies have paid settlements of hundreds of millions or billions of dollars in the face of threatened prosecution or trial in civil false claims cases. Governments and other private actors do not suffer the same burdens on their speech, even though the pharmaceutical manufacturer likely has the most complete, up-to-date, and useful information about the product. Moreover, even when it makes economic sense for a pharmaceutical manufacturer to seek FDA approval for a new use, the FDA can take many months or even years to approve such new uses. Patients — especially those with life-threatening conditions — cannot wait for the agency to act. Even with recent changes in the FDCA, if a new use concerns a rare disease — or the drug is off-patent — it may not be economical for the pharmaceutical manufacturer to seek approval of a new use.

Regulatory Transparency Project

And, sadly, this is lethal regulatory intransigence and tyranny. It has killed, is killing, and will continue to kill people. And all for no valid purposes other than keeping the manufacturers of pharmaceuticals on their proverbial knees before the Deep State and maintaining the perceived relevance – and budget appropriations – of the FDA.

With the FDA censoring what drug makers can publish – even when it’s true, simply presented, and efficacious – many doctors aren’t able to know that there are alternative, off-label, treatment options available for their patients. Similarly, this censorship makes it functionally and legally impossible for health insurance providers to cover the costs of those prescriptions. That has, can, and will kill people – all for the sake of the powermongers of the FDA.

This seems to be no longer be true, but in my day, if you wanted to try CHANTIX to aid you in stopping smoking, insurance wouldn’t cover it because it was an off-label use of the medication.

And, if we’re to even begin to believe the current, #Woke sorts, this is systemic racism since non-Whites, especially the Blacks, are less likely to be able to afford medications that aren’t covered by health insurance. Hence, they’re “disproportionately impacted” by the FDA’s lethal regulations upon free speech involving medicines’ uses.

Honestly, American or Democrat, everyone should be calling for a end to the FDA’s lethal regulation and censorship and calling upon the organization to account for and defend its regulations – which aren’t laws but carry the weight thereof without Legislative oversight – or be forced to abandon them.

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The FBI Raid Chart

The FBI Raid Chart
The FBI Raid Chart

Ah yes. The FBI Raid Chart. It’s been around since Obama weaponized the entirety of the DOJ against the true-born and rightly-raised People of America. It’s just gotten worse, more overt, and less apologetic in recent years. What they did to President Trump and his family is just the most recent and most egregious offense by The Democrats’ jackboots.

Because Only Certain People Can Be Targeted
Because Only Certain People Can Be Targeted

And this is the one thing our self-proclaimed domestic enemies, the Democrats and their sorts, either don’t understand or blindly deny. A lot of us Americans either aren’t especially bothered by the FBI raiding President Trump’s home or, like me, are ambivalent due to this situation being fairly complex. What were far more than merely bothered by is that others haven’t been raided or even investigated and it’s more than obvious that the FBI’s choice of targets have been totally and solely politically motivated.

It’s obvious to a large number of us, irrespective of how we feel about President Trump, that the entirety of the federal agency apparatus and related personnel have been suborned by Democrats and are et al and in toto illegitimate, an enemy occupying force, and a clear and present existential threat to ourselves, our loved ones, and our nation.

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Biden Backpedaling

Biden Confused and Backpedaling after publicly declaiming 150 million American citizens as existential threats to Democracy

Biden, ever the gaffe-prone, war-seeking, dodderer, is now frantically backpedaling away from his recent Kafkaesque declaration that huge swaths of the American citizenry are existential threats to Democracy and the nation.

Of course, like most of what the Democrats’ POTUS does, he’s not at all good at it. But then, bicycles never were his forte… and neither was any real form of statesmanship.

Personally, when something like Biden labels me, mine, and every ally I have as existential threats to Democracy and America, there’s no backpedaling away from that. The Rubicon has been crossed.

They're An Existential Threat To The Nation
They’re An Existential Threat To The Nation!

And yes; delivering your call to arms in a staged production that looks like someone combined the “best” of Stalin’s and Hitler’s set pieces doesn’t help one bit, because those style elements are proven to be powerful and effective. That makes it clear that the choice to use them was deliberate and designed to rile up the Democrats’ base.

Bialystok anyone? Kristallnacht? History has – or should have – taught us that certain words, if delivered in certain manners and settings, can be used cause followers to shed their normal compunctions and commit atrocities upon segments of populations that they hate or are envious of.

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How They'll Really Do It

Disarming Americans – How They’ll Really Do It

I recently posted some sarcastic gallows humor about American patriots “dealing with” government thugs coming to take our firearms. And yeah, it was sort of a bit of feel good patriotism. But it was just and nothing more than a bit of sarcastic humor. Let nobody believe that when – and it’s no longer if, unless we remove the Democrats – the government decides that the 2nd Amendment is moot and begins fully or mostly disarming the People, that it’ll be in a way where the majority of the citizenry will do anything about it.

In other words, this man is wiser than most of us.

Fuck Around And Find Out

The phrase, “Fuck Around And Find Out” has been gaining a lot of exposure and popularity across social media among Americans of or near my age. Apparently, Americans of Generation Jones and Generation X have co-opted the phrase from the Farther Left. Indeed, there’s a lot of my people using the phrase in response the Democrat gun-grabbers’ voiced desires.

The problem is that so many of us are forgetting that this applies to us as well and equally. Do nothing now, before the Democrats can get their de facto firearm confiscations underway is “Fucking Around” and we, the People could easily end up “Finding Out” exactly what that means for us, our children, and our children’s children.

If we look on and do nothing now, by the time we do do something to defend ourselves, or Heaven-granted rights, and our families, it’ll be far too little and far too late. And our domestic enemies know this and are counting upon it.

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You’re Being Told…

You're Being Told...
You’re Being Told…

It’s summertime and, as such, various governments of Democrat-controlled urban population centers are telling residents to turn off or turn down their ACs to prevent once again overwhelming their poorly maintained power grids. At the same time though, Democrats and the sorts which vote them into office are telling us all – and, are trying to force us – to trade in our gasoline-powered cars and trucks for electric vehicles. 🙄

The first real question facing Americans is whether this is simple, Leftist idiocracy, a matter of callous ends justifying the means, or a planned crisis to allow Democrat state and local governments to take full, direct control of the power utilities in their areas. The second real question facing Americans is how far will we go to- and how permanently will we remove the threat these Democrats pose to our nation and our People.

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